RoboGene HDV RNA Quantification Kit 2.0

CE-IvD certified for a wide range of real-time PCR devices

 

Referenced to the WHO 1stInternational Standard for HDV RNA

 

Most sensitive assay

 

 

Intended use

The RoboGene HDV RNA Quantification Kit 2.0 is intended for real-time PCR quantification of Hepatitis D Virus (HDV) RNA in human EDTA plasma or serum samples using the INSTANT Virus RNA/DNA Kit. Two kit versions are available: low profile strips 0.1 ml (white) for LightCycler® 480 and 7500 Fast real-time PCR systems and regular profile tubes 0.2 ml (clear) for application on Rotor-Gene™ 3000/6000/Q, respectively. The assay is purposed for the clinical management of patients with chronic HDV infections in conjunction with symptoms and other laboratory markers of the disease.

This test is intended to assess viral response to antiviral treatment as measured by changes in plasma and serum HDV RNA levels. Additionally, in a course of antiviral therapy the probability of a sustained viral response can be judged.

The RoboGene HDV RNA Quantification Kit 2.0 is not intended for use as a screening test for the detection of HDV RNA in blood or blood products or as a diagnostic test to confirm the presence of HDV infection.

Status

CE-IvD

Validated extraction kits

Automization manual
Extraction kit name INSTANT Virus RNA/DNA Kit
Sample volume 400 µl
Sample specimen Plasma (EDTA) and Serum

 

Validated real-time PCR platforms

LightCycler® 480 (Roche)

7500 Fast (Applied Biosystems)

Rotor-Gene® 3000/6000/Q (Corbett Research/Qiagen)

Specifications

LoD with manual purification: 6 IU/ml

Linear range: 5 to 1x108 IU/ml

Genotypes: 1 - 8

Order information

Item number for Item number for  
regular profile tubes 0,2 ml (clear) low profile strips 0,1 ml (white) Kit size
847-0207400544 847-0207400584 32 reactions
847-0207400542 847-0207400582 96 reactions

 

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